NORADRENALINE (NOREPINEPHRINE) 1 mg / ml Concentrate for solution for infusion

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

The name of this medicinal product is Noradrenaline (Norepinephrine) 1 mg/ml concentrate for solution for infusion, but will be referred as Noradrenaline (Norepinephrine) Concentrate throughout the whole leaflet.

1. What Noradrenaline (Norepinephrine) Concentrate is and what it is used for
2. What you need to know before you are given Noradrenaline (Norepinephrine) Concentrate
3. How you are given Noradrenaline (Norepinephrine) Concentrate
4. Possible side effects
5. How to store Noradrenaline (Norepinephrine) Concentrate
6. Contents of the pack and other information

• if you are allergic to noradrenaline or to any of the other ingredients of this medicine (listed in section 6);
• if you are hypotensive (have low blood pressure) that has been caused by hypovolaemia (low blood volume);
• if you are taking some anaesthetics such as halothane or cyclopropane (this may increase the risk of irregular heart beat).

Talk to your doctor, pharmacist or nurse before you are given Noradrenaline (Norepinephrine) Concentrate:

• if you have extravasation (leakage of a fluid out of its container into the surrounding area) risk;
• if you have pallor (loss of skin colour) or painful and cold extremities that may become purple to very dark/black;
• if you have major left ventricular dysfunction (a heart condition);
• if you have coronary (blood clot inside a blood vessel of the heart), mesenteric (blood clot in a vein that drains blood from the intestine), or peripheral vascular thrombosis (blood clot in the vein of arm or leg);
• if you have hypotension (low blood pressure) following myocardial infarction (heart attack);
• if you have Prinzmetal's variant angina;
• if you have heart rhythm disorders during your treatment - you will need a reduced dose;
• if you have hyperthyroidism (thyroid gland problem) or diabetes mellitus;
• if you are elderly.

Your blood pressure and heart rate will be checked frequently during your treatment to avoid hypertension (high blood pressure).

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Noradrenaline (Norepinephrine) Concentrate may affect or be affected by other medicines. In particular, tell your doctor if you are taking any of the following:

• Halothane, cyclopropane: these medicines are anaesthetics, they cause insensibility to pain and are used before some operations. If you are taking these medicines as well as Noradrenaline this may increase the risk of irregular heart beat.
• Amitriptiline, imipramine, trimipramine, moclobemide, iproniazide, phenelzine, fluoxetine, sertraline: these medicines are used for treatment of depression. Taking any of these medicines together with noradrenaline can dangerously increase its concentration in the blood and therefore its pressor action.
• Linezolid, an antibiotic (medicine used to treat infections caused by bacteria and other microorganisms), can dangerously increase noradrenaline concentration in the blood and therefore its pressor action, when taken together.
• Alpha and beta-blockers: if you are taking these medicines as well as noradrenaline this may increase the risk of severe hypertension (high blood pressure).
• Thyroid hormones, cardiac (heart) glycosides, anti-arrhythmics: if you are taking these medicines as well as noradrenaline this may cause increased cardiac (heart) effects.
• Ergot alkaloids or oxytocin may enhance the vasopressor and vasoconstrictive (increasing blood pressure) effects.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before you are given this medicine. Then your doctor will decide if you should be given this medicine.

Since this medicine will be given to you in a hospital, your doctor will inform you when you will be able to drive or use machines.

This medicine contains less than 1 mmol sodium (23 mg) per 4 ml ampoule, that is to say essentially 'sodium-free'.

This medicine contains 26.4 mg sodium (main component of cooking/ table salt) in each 8 ml ampoule. This is equivalent to 1.3 % of the recommended maximum daily dietary intake of sodium for an adult.

The dose of noradrenaline depends on the condition of the patient. Your doctor will know the best dose to use. Noradrenaline (Norepinephrine) Concentrate is first diluted (either with dextrose 5%, 0.9% sodium chloride, or with isotonic dextrose saline) and then usually infused into a vein. It should not be mixed with other medicines. The dose can then be adjusted using a pump according to the response to treatment, with the aim to establish a normal blood pressure. The initial dose is 0.4 to 0.8 mg per hour of Noradrenaline (Norepinephrine) base.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme: Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

The active substance is noradrenaline tartrate.

Each ml of concentrate for solution for infusion contains 2 mg noradrenaline tartrate, equivalent to 1 mg noradrenaline base.

Each 4 ml ampoule contains 8 mg noradrenaline tartrate equivalent to 4 mg noradrenaline base.

Each 8 ml ampoule contains 16 mg noradrenaline tartrate equivalent to 8 mg noradrenaline base.

The other ingredients are sodium chloride, sodium hydroxide or hydrochloric acid and water for injections.

Clear, colourless or slightly yellowish solution of pH 3.0 to 4.0 packaged in a clear glass ampoule of 4 ml or 8 ml.

Boxes of 10, 50 or 100 ampoules.

Not all pack sizes may be marketed.